Calibration and Image Processing Devices, Methods, and Systems

ABSTRACT

In part, the invention relates to systems and methods of calibrating a plurality of frames generated with respect to a blood vessel as a result of a pullback of an intravascular imaging probe being pullback through the vessel. A calibration feature disposed in the frames that changes between a subset of the frames can be used to perform calibration. Calibration can be performed post-pullback. Various filters and image processing techniques can be used to identify one or more feature in the frames including, without limitation, a calibration feature, a guidewire, a side branch, a stent strut, a lumen of the blood vessel, and other features. The feature can be displayed using a graphic user interface.

FIELD OF INVENTION

In part, this invention relates to imaging systems, and morespecifically to image data collection probes, data collection systems,optical coherence tomography and related methods.

BACKGROUND

Optical coherence tomography (OCT) is an interferometric imagingtechnique with widespread applications in ophthalmology, cardiology,gastroenterology and other fields. In interferometric imaging, lightfrom a known and controlled optical path (the ‘reference path’) iscaused to interfere with light returned from an unknown path such thatinformation about this unknown path (the ‘sample path’) may bedetermined by an analysis of the resulting interferogram. Theinterferogram contains the depth location information of structureswithin the sample being analyzed. A particular advantage of OCT is itsinherent compatibility with fiber optics making it a nearly idealimaging modality for non-invasive or minimally invasive medicalprocedures.

In general, for OCT systems, the lengths of the sample and referencepaths are matched to ensure the interference effect being recordedcorresponds to a desired scan region within the sample. In the case ofrelatively long optical catheters required in many procedures(approximately 1.5 to 2 meters is common) such matching can be difficultto achieve. Furthermore, the optical fibers used in these catheters caneasily stretch or contract several millimeters during use.

When using OCT, the optical ‘zero-point’ is critical. This defineswhere, in the image space, the so-called reference plane exists. Byconvention, surface planes are in the x-y plane, and the depth occursalong the z-axis. In a microscope application for example, it may bebeneficial to set the zero point at the surface of the microscope slide,so specimens can be measured against this known surface. For a catheterinserted in a lumen such as a blood vessel, the most useful referenceplane is the outer surface of the catheter tip itself, and all distancesare measured outward from this location.

OCT systems typically use an adjustable reference path within theoptical imaging equipment to adjust to each catheter as it is used. Thisis generally handled using a reference motor which can move a reflectorsuch as a reference mirror back and forth to adjust the reference path.

A given medical application may use many disposable catheters per day;all interfaced to the same imaging equipment. Thus, while the primarypath length adjustment can work quite effectively, it usually requiresan initial adjustment by a skilled operator who understands the opticalreflection pattern or ‘signature’ of the catheters that will be recordedby OCT to determine how to adjust the reference path to coincide withthe outer surface of the catheter tip.

Again, the adjustment of the image zero-point, or reference planelocation is performed by adjusting the primary path-length of thereference arm. This adjustment is often termed ‘z-offset’ of thereference arm and is controlled via a motor, called simply the z-offsetmotor, and a movable reference mirror. By convention, the instrumentz-offset is zero when the sample arm length (catheter) is manufacturedexactly as designed; is negative when the catheter is too short; andpositive when the catheter is too long. Motor movements can be used toadjust the reference path in a consistent manner for differentcatheters.

OCT catheter-based probes typically include a beam directing structuresuch as lens or reflector placed at their distal tip to focus and directlight for scanning purposes. The light typically propagates through oneor more transparent sheaths that comprise the catheter outer structurewith an optical fiber disposed therein and in optical communication withthe lens or reflector. Each of the optical interfaces can cause areflection that will be detected by OCT. Hence, it may be challenging todetermine which of those reflections corresponds to the desired opticalreference point (‘zero-point’) of the system.

Since measurements are made based on this zero-point setting, setting itcorrectly can significantly affect the results of a given medicalapplication. Furthermore, because there may be several closely spacedand similar intensity reflections, the use of software to detect theproper zero-offset (‘z-offset’) is problematic and unreliable.Additionally, as a further complexity, because imaging systems and thedisposable catheter-based based probes such systems use change overtime, software for one system is generally not designed for differentOCT probes. Calibration drift and other imaging artifacts can alsoaffect image quality during a review of frames post-pullback.

Therefore, methods, devices and systems suitable for calibrating an OCTsystem are needed. Given the complexity of optical interface signals,additional techniques, software modules, and devices to address suchsignals in the context of calibrating a data collection probe or theunderlying data are needed. In addition, image processing techniquessuitable for dealing with calibration drift and related issues after apullback is complete are also needed. Further, the methods, devices, andsystems should be able to work with different types of disposable datacollection probes. The present invention addresses these needs andothers.

SUMMARY

In part, the invention relates to various image data collection probedesigns that include a calibration feature to distinguish probe typesand calibrate a data collection system when using a given type of datacollection probe. Methods and systems that are configured to performcontinuous calibration using image processing techniques after apullback is complete that do not rely on motor related offset changesare also embodiments of the invention. The placement or properties of agiven calibration feature can be used to identify different types ofdata collection probes. In turn, the specific calibration steps that canbe performed for a given catheter type can be specified upon identifyingthe type of catheter being used with an OCT system.

The invention also includes various image data processing softwaremodules and a modular or encapsulated for such modules as well asprocessing methods relating to their sequential arrangement. OCT dataframes can be prefetched from a database or other data store or memoryfor use by a first software module, such as a continuous calibrationmodule, and subsequently prefetched for a second software module, suchas side branch detection. This prefetching is extendable to a pluralityof software modules such as imaging processing and filtering modules.

The use of intravascular imaging probe structural components and theiroptical properties such as associated intensity patterns in a frame ofOCT image data can be used to identify calibration features of interestor instances where features are misidentified as a calibration featureof interest. For example, a dark or low intensity region in an OCT imagethat maps to a particular structural component and its optical signatureregions can be used as part of a filtering or pattern recognitionalgorithm to screen out erroneous optical interface signals whensearching for a calibration feature of interest. In this way, spliceshaving reflections, glass components that are substantiallytransmissive, and light scattering calibration features can beidentified with greater accuracy. In one embodiment, calibrationfeatures which move relative to the data collection probe during apullback are searched to perform continuous calibration after thepullback is complete using imaging processing methods and softwaremodules.

The invention provides, in part, methods of detecting a calibrationfeature disposed in a vessel having a vessel wall, the vessel scannedusing an intravascular imaging probe. The method includes the steps of:storing image data obtained during a pullback through the vessel in amemory device, the image data comprising a plurality of frames, eachframe comprising scan lines; averaging scan lines for a first frame ofthe plurality of frames to obtain a speckle reduced first frame;identifying a region in the speckle reduced first frame in which thecalibration feature is estimated to appear; identifying candidatesamples of the calibration feature; identifying a region defined by thecandidate samples using a thickness of at least a portion of thecalibration feature; and fitting a curve to the candidate samples todefine a boundary of the calibration feature in the speckle reducedfirst frame.

The invention also provides methods of detecting a calibration featuredisposed in a vessel having a vessel wall, the vessel scanned using anintravascular imaging probe. The method includes the steps of: storingimage data obtained during a pullback through the vessel in a memorydevice, the image data comprising a plurality of frames, each framecomprising a plurality of scan lines; averaging the plurality of scanlines for a first frame of the plurality of frames to obtain a specklereduced first frame; identifying a region in the speckle reduced firstframe in which the calibration feature is expected to appear;identifying candidate pixels of the calibration feature using a firstspatial filter; identifying a region defined by the candidate pixelsusing a second spatial filter having a thickness of at least a portionof the calibration feature; and fitting a curve to the candidate pixelsto define a boundary of the calibration feature in the speckle reducedfirst frame.

In some embodiments, the intravascular imaging probe comprises anoptical fiber and a beam director in optical communication with theoptical fiber. The calibration feature can be a substantially ellipticalcross-section of a substantially transparent curved cover comprising apolymer. The elliptical cross section can have a first annular regionand a second annular region, and the second annular region can be dopedwith a light scattering material. The thickness can be an annularthickness of the second annular region and wherein the second annularregion is disposed concentrically within the first annular region.

In some embodiments, the method can include the step of receiving thethickness from a device attached to the intravascular imaging probe.

In some embodiments, the method can include the step of searching forthe second annular region using the thickness.

In some embodiments, the method can include the steps of rotating theoptical fiber and the beam director within the calibration feature andgenerating an image of a cross-section of the blood vessel. The imagecan include a first annular region having a first optical intensity anda second annular region having a second optical intensity, and thesecond optical intensity brighter than the first optical intensity.

In some embodiments, the method can include the steps of: averaging scanlines for a second frame of the plurality of frames to obtain a specklereduced second frame; identifying a region in the speckle reduced secondframe in which the calibration feature is estimated to appear;identifying candidate samples of the calibration feature using a firstspatial filter; identifying a region defined by the candidate samplesusing a second spatial filter having a thickness of at least a portionof the calibration feature; and fitting a curve to the candidate samplesto define a boundary of the calibration feature in the speckle reducedsecond frame.

In some embodiments, the method can include the steps of: averaging theplurality of scan lines for a second frame of the plurality of frames toobtain a speckle reduced second frame; identifying a region in thespeckle reduced second frame in which the calibration feature isexpected to appear; identifying candidate pixels of the calibrationfeature using a first spatial filter; identifying a region defined bythe candidate pixels using a second spatial filter having a thickness ofat least a portion of the calibration feature; and fitting a curve tothe candidate pixels to define a boundary of the calibration feature inthe speckle reduced second frame.

In some embodiments, the method can include the steps of: identifying adark region having a first intensity in one or more of the scan lines ofa frame; and excluding optical signals having a second intensityappearing in the dark region if the second intensity is greater than thefirst intensity.

In some embodiments, the method can include the steps of: identifying adark region having a first intensity in a plurality of the frames; andexcluding optical signals having a second intensity appearing in thedark region if the second intensity is greater than the first intensity.

In some embodiments, one or more of the indentifying steps are performedusing one or more filters.

In some embodiments, the method can include the step of rejecting imagedata associated with the boundary of the calibration feature, when ashape of the boundary is irregular or exceeds a shape threshold.

The invention also provides, in part, intravascular image dataprocessing systems. The system can include a memory and a processor incommunication with the memory. The memory includes instructionsexecutable by the processor to cause the processor to: continuouslycalibrate a plurality of frames comprising cross-sectional images usingan elliptical calibration feature that changes between two or moreframes of the plurality of frames, the plurality of frames comprisingdata collected during a pullback of a probe through a blood vessel;detect a guidewire in the plurality of frames; and display a pluralityof continuously calibrated frames.

In some embodiments, the continuously calibrating includes identifyingthe elliptical calibration feature in at least a majority of theplurality of the frames.

In some embodiments, identifying the elliptical calibration feature isperformed using one or more constraints selected from the groupconsisting of non-concentric positioning of calibration feature, acircular profile of calibration feature, a perimeter measure ofcalibration feature, an area measure of calibration feature, a thicknessof a brighter annular subset of the calibration feature, a thickness ofa brighter annular subset of the calibration feature and thickness of adoped region of the calibration feature.

In some embodiments, the system can include instructions executable bythe processor to cause the processor to divide the plurality of framesinto a plurality of windows and fit a curve relative to a measurement ofthe elliptical calibration feature across the plurality of windows.

In some embodiments, the system can include instructions executable bythe processor to cause the processor to detect one or more side branchesin the continuously calibrated frames and display a side branch on oneor more of the continuously calibrated frames.

In some embodiments, the system can include instructions executable bythe processor to cause the processor to detect a lumen of a blood vesselon a per frame basis for the continuously calibrated frames and todisplay the lumen of the blood vessel in the continuously calibratedframes.

In some embodiments, the system can include instructions executable bythe processor to cause the processor to detect a guide catheter on a perframe basis for the continuously calibrated frames.

In some embodiments, the system can include instructions executable bythe processor to cause the processor to detect a stent strut and todisplay a stent strut on one or more of the continuously calibratedframes.

In some embodiments, the system can include instructions executable bythe processor to cause the processor to: detect one or more sidebranches on a per frame basis in the continuously calibrated frames;detect one or more stent struts in the continuously calibrated frames ona per frame basis; detect a lumen of a blood vessel on a per frame basisfor the continuously calibrated; and display a side branch, one or morestents struts, and the lumen on one or more of the continuouslycalibrated frames.

In some embodiments, the elliptical calibration feature includes a firstborder, and the border changes between the two or more frames.

In some embodiments, the elliptical calibration feature includes asecond border disposed within the first border, and the second borderchanges between the two or more frames.

In some embodiments, continuously calibrating a plurality of framesincludes calibrating each scan line prior to generating a frame ofcalibrated scan lines.

In some embodiments, the system can include instructions executable bythe processor to cause the processor to: generate an alert in responseto a shape of the first border or a loss of calibration feature tracking

In one embodiment, one or more filter kernels are configured to identifyone or more intensity patterns or data collection probe featuresincluding without limitation: a calibration feature such as an intensitypattern from an annular doped region of a sheath, a region of lowintensity such as a dark ring or band associated with a glass or othersubstantially non-reflective structure a reflection from a splicebetween a first section of an optical fiber and a second section of anoptical fiber, a reflection from a potting layer, and a calibrationfeature disposed in the imaging field which is imaged at differentlocations as a probe rotates.

In one embodiment, a filter kernel can be applied on a per scan linebasis. In one embodiment, a filter kernel can be configured to match ahigh or a low region of a ring along a given scan line. In oneembodiment, the first section and the second section are sections of asample arm of an interferometer. In one embodiment, the selection of aparticular filter kernel is triggered based upon a thickness of a dopedannular calibration feature. In one embodiment, a thickness of a dopedannular calibration feature, a scattering particle concentration of adoped annular calibration feature, or other probe-specific calibrationfeatures can be encoded using a tag which can be read by a scanner andtransmitted to a calibration software module for selecting a particularfilter kernel in response to the encoded thickness. In one embodiment,the tag is a near field tag or an RFID tag. The scanner can be part of aprobe interface unit in one embodiment.

In one embodiment, a filter kernel such as a convolution matrix isimplemented as a matrix including rows and columns and elementsconfigured to perform image processing for performing intensifying,sharpening, pattern identification, detection, tracking and other imageprocessing tasks. The filter kernel can be used in various preprocessingand other processing stages to perform image processing on OCT imagedata or other image data. In one embodiment, the term “prefetch” meansto obtain data from one source in advance of such data being requestedor processed by another system or process. Notwithstanding theforegoing, the scope of the terms discussed herein is not intended to belimiting, but rather to clarify their usage and incorporate the broadestmeaning of the terms as known to those of ordinary skill in the art.

In one embodiment, calibration of frames of image data can be performedafter a pullback is complete using image processing techniques ratherthan using motor position to affect a calibration. In one embodiment,different optical fiber changes following a motor-based calibration canbe handled in software and performed on a per frame basis. For example,error associated with optical fiber stretching or blood vessel movement,such as due to a heart muscle contraction, can be corrected for on a perframe basis using a continuous calibration processes such as an imageprocessing module. Tracking of moving or otherwise deforming calibrationfeatures on a per frame basis and accounting for false signals that canmimic calibration features are embodiments of the invention.

In one embodiment, an elongate sheath having a substantially circular orelliptical cross-section is doped with a plurality of scatteringelements in a pattern such as a ring, a band, or other annular region ormultiple annular regions. An optical probe can be pulled back withrespect to the doped sheath such that image frames of data are generatedin which the appearance of the pattern of the doped region changes,moves, or deforms in one or more frames along the pullback.

In one embodiment, the elongate sheath is configured to transmit lightsuitable for generating an image of a blood vessel or a componentthereof. In one embodiment, substantially circular or ellipticalcross-section includes a first substantially annular region thatincludes scattering elements and a second substantially annular regionthat is substantially free of scattering particles. In one embodiment, acalibration feature includes a ring that defines a first annular subsetand a second annular subset. In one embodiment, the scattering particlesare TiO₂ particles.

A calibration feature can include one or more filters use to track aone-dimensional or a two-dimensional feature that appears across aplurality of frames of image data. Optical signatures of catheters canbe identified based on the back scattering signals received fromcalibration features or other sheaths used in a probe.

BRIEF DESCRIPTION OF DRAWINGS

The figures are not necessarily to scale, emphasis instead generallybeing placed upon illustrative principles. The figures are to beconsidered illustrative in all aspects and are not intended to limit theinvention, the scope of which is defined only by the claims.

FIG. 1A is a schematic diagram depicting various data collection probeconfigurations suitable for use with an optical coherence tomographysystem and one or more calibration processes according to anillustrative embodiment of the invention.

FIG. 1B is a schematic diagram depicting an OCT data collection systemand an intravascular data collection probe according to an illustrativeembodiment of the invention.

FIGS. 2A-2D are schematic diagrams depicting cross-sections of acatheter-based intravascular data collection probe according to anillustrative embodiment of the invention.

FIG. 3A is a schematic diagram depicting a cross-section of acatheter-based intravascular data collection probe along with additionaldetails relating to scan lines and certain calibration featuresaccording to an illustrative embodiment of the invention.

FIG. 3B is a frame of optical coherence tomography image data obtainedwith respect to a blood vessel at a first frame using an OCT probe thatincludes various optical features including one or more calibrationfeatures according to an illustrative embodiment of the invention.

FIG. 3C is a frame of optical coherence tomography image data obtainedwith respect to a blood vessel at a second frame using an OCT probe thatincludes various optical features including one or more calibrationfeatures according to an illustrative embodiment of the invention.

FIG. 3D is a frame of optical coherence tomography image data obtainedwith respect to a blood vessel including one or more calibrationfeatures according to an illustrative embodiment of the invention.

FIG. 4 is a schematic diagram depicting various high level steps andstages relating to collecting image data with respect to a blood vesseland post pullback data processing according to an illustrativeembodiment of the invention.

FIG. 5 is a schematic diagram that includes the steps and stages of FIG.4 and also depicting additional details relating to steps and stagesrelating for collecting image data with respect to a blood vessel andpost pullback data processing according to an illustrative embodiment ofthe invention.

FIG. 6A is a flow chart reciting various steps suitable for tracking oranalyzing a calibration feature such as doped sheath in frames ofoptical coherence tomography data according to an illustrativeembodiment of the invention.

FIG. 6B is two versions of an image depicting a cross-sectional view ofa blood vessel obtained using optical coherence tomography in which oneversion has undergone line averaging and the other version has notaccording to an illustrative embodiment of the invention.

FIG. 6C is an image of a cross-section of an optical coherencetomography image showing a blood vessel with various regions including adoped sheath being identified with a graphical overlay.

FIG. 7 is a schematic diagram of a image data processing moduleconfigured to direct the processing of image data relative to a softwaremodules described herein such as, for example, the modules in theprocessing pipeline paths of FIG. 8.

FIG. 8 is an arrangement of image processing software modules alongdifferent processing pathways based upon physiological and otherconsiderations to improve the results of the application of suchmodules.

FIG. 9A is a schematic diagram depicting an intravascular image datacollection probe having a beam director and one or more optical fibersplices and pattern recognition features relating thereto according toan illustrative embodiment of the invention.

FIG. 9B is a schematic diagram illustrating manufacturing variability'simpact on a calibration feature which can be addressed according to anembodiment of the invention.

FIGS. 10A-10B are cross-sectional and longitudinal mode views of an OCTgenerate image depicting error states that can be monitored for anidentified in response to a loss of lock or deviation detected by acalibration software module according to an illustrative embodiment ofthe invention.

FIG. 11 is a flow chart of a curve fitting process suitable forinterpolating or calibrating between a plurality of OCT frames accordingto an embodiment of the invention.

FIG. 12 is a schematic diagram showing a doped sheath and a magnifiedview of its layers and OCT signal changes based on the thickness of suchlayers according to an illustrative embodiment of the invention.

DETAILED DESCRIPTION

In part, the invention relates to various methods of collecting andprocessing data such as frames of OCT data. In one embodiment, a frameof OCT data or image data includes a cross-sectional image generatedfrom a plurality of scan lines obtained using a rotatable intravascularprobe. The cross-sectional images or other images are generated usinginterference-based depth measurements obtained with respect to a samplesuch as a blood vessel using a data collection probe. One embodiment ofthe invention relates to methods of calibrating a data collection systemsuch as an OCT system used in conjunction with a data collection probe.Various types of calibration can be used such as manual calibration oruser triggered automatic calibration using a mirror and motor initiatedchanges. In part, the invention relates to continuous calibration methodembodiments that calibrate frames of OCT data from a pullback inconjunction with an image processing module rather than motoradjustments.

Data collection probes, such as OCT probes, IVUS probes, pressurewire-based probes, fractional flow reserve probes, probe combining theforegoing technologies, are inserted into a subject and then used toimage a particular blood vessel or otherwise collect data with respectto such a vessel. As a result, the data collection probes are disposablein nature. The feature set and method for calibrating such probes canchange over time. Some of these probes may be backwards compatible andforwards compatible with existing imaging systems and systems that willbe developed in the future. In contrast, some of the probes may only becompatible with certain types of OCT systems or only certain features ofa given probe can be used with a given system. Accordingly, being ableto identify different types of probes and how they work with a given OCTsystem is a desirable design feature. In addition, the calibrationroutine used with a given current generation probe and a legacy probetype may be different. As a result, detecting such differences allowsdifferent calibration routines to be used.

In addition, the data collection systems that interface with and receivedata from such probes also change over time. As a result, one aspect ofthe invention relates to recognizing and calibrating different types ofdata collection probes. In part, in one embodiment, differentcalibration routines are selected from a plurality of software modulesor data processing stages based upon the type of data collection probethat is coupled to a particular data collection and processing system.

In FIG. 1A an image data collection and processing system 1 is shownthat is configured to interface with an optical fiber 3 that is part ofa data collection probe 5. FIG. 1B shows additional details relating tothe image data collection and processing system 1 for an embodiment inwhich it is an OCT data collection and processing system. The probe 5 isshown in an in-vivo environment with respect to a blood vessel B havinga vessel wall VW that defines a lumen L. The blood vessel B alsoincludes a side branch SB.

The probe 5 includes a probe tip which includes or is in opticalcommunication with an optical fiber 3. The optical fiber 3 and the tipof the probe 5 are disposed within one or more sheaths such as cathetersheath 7. The probe tip can include various elements such as an angledbeam director or a lens cap as well as transducers for other imagingmodalities. The optical fiber 3 of the probe 5 can also include a torquewire disposed around the fiber 3. The probe transmits light, shown as λ,in the lumen L and receives light scattered from the vessel wall VW.

In one embodiment, the optical fiber 3 is a portion of a sample arm ofan interferometer. A data collection probe 5, such as an OCT probe, canbe used to collect depth information suitable for imaging a sample suchas a blood vessel. For example, a set of frames of image data, such asframe F1 and frame F2, are generated based upon optical signals sent andreceived by such a probe 5. A cross-sectional image of blood vessel isformed by a collection of scan lines as the probe rotates.

The probe 5 is pulled back through the blood vessel B as the fiber 3 andprobe tip within sheath 7 rotates such that the beam of light λ sent tothe vessel wall from the probe tip traces a spiral as it moves along thesection of the blood vessel B being imaged. This section has a specifiedpullback distance. A set of frames are obtained with regard to thepullback distance in one embodiment. The probe 5 slides within thesheath 7 as it is pulled back through the blood vessel. As a resultdifferent frames are obtained with regard to different sections of theblood vessel and through different sections of the sheath 7. Forexample, frame F1 and frame F2 represent in FIG. 3B and FIG. 3Ccorrespond to imaging through the sheath 7 at different locations andshowing images generated with regard to different calibration featuresas a result of the different sections of sheath 7 being imaged.

As a further example, the sheath 7 may move and compress along the bloodvessel B and have different elliptical cross-section that varies or movealong the frames as shown in frames F1 and F2. In part, one aspect ofthe invention relates to performing calibration of a plurality of framesof OCT data using a calibration feature 10 that changes across frames aswell as calibration features that do not move across frames. A fiberfixed calibration feature 10 a that is directly attached to the opticalfiber 3 such as probe embodiment D1 of FIG. 2A is different from acalibration feature in the imaging field that moves and changes as theprobe 5 is pulled back such as calibration feature 10 c in FIGS. 2C and2D. In FIG. 2A, the probe D1 includes a calibration feature that isattached to the optical fiber 3 as a concentric layer and thus moveswith and is consistently imaged the same way by the probe D1.

Different types of data collection probes can be used with a datacollection system 1 and the system is configured to recognize thedifferent types of probes such as probe 5 and other designs. Embodimentsof the invention are also directed to the data collection probes andcomponents thereof. An image data collection probe 5 such as an OCTprobe can include a calibration feature 10 that can be identified by oneor more modules 12 of system 1 in frames of image data obtained during apullback. The software modules 12 can include various calibrationsoftware modules, image processing software modules, graphic userinterface, cross-sectional area display, longitudinal or L-mode display,a spline or interpolation software module, prefetch software module orarchitecture, and other software modules as described herein.

In one embodiment, the calibration feature 10 includes a geometricstructure or pattern or controlled arrangement of backscatteringparticles to distinguish probe types and calibrate a data collectionsystem when using a given type of data collection probe. The placementor properties of a given calibration feature can be used to identifydifferent types of data collection probes. In turn, the specificcalibration steps, such as steps 1-4 shown in FIG. 4 that can beperformed for a given catheter type can be specified upon identifyingthe type of catheter being used with an OCT system. For example, withregard to FIGS. 2A-2C, the different calibration features 10 a, 10 b, 10c, and combinations thereof can be used as signatures to differentiateprobe types and trigger probe specific calibration software routes.Different calibration modules can be stored in memory as part ofsoftware modules 12 used by the system 1.

In one embodiment, the optical fiber 3 interfaces with a patientinterface unit 14 that includes a dock or coupler configured to receivean end face of optical fiber 3 or an optical fiber coupled to opticalfiber 3. The PIU can include a tag reader such as an RFID reader to readtags attached to the probe 5. Information relating to calibrationfeatures such as the thickness or concentration of doped sheaths orlayers of the probe can be encoded thereon.

The top portion of FIG. 1A show various possible exemplarycross-sections D1, D2, D3, D4, and D5 of a given probe 5. As shown, adata collection probe 5 can include a plurality of elongate nestedlayers or sheaths and an optical fiber 3 disposed therein. The datacollection probe can include a calibration feature such as thecalibration feature 10 and other specific examples of calibrationfeatures such as features 10 a, 10 b, 10 c and others shown anddiscussed in more detail herein.

The data collection probe 5 can include a plurality of surfaces thatprovide reflections that can be used to identify one or more componentsof a given type of data collection probe. The layers shown are typicallyelongate cylindrical objects such as sheaths that are disposed oneinside of the other. In one embodiment, a support material such as apotting material surrounds an optical fiber 3 disposed along thelongitudinal axis of the probe in various embodiments. An example of afiber 3 having potting material 20 surrounding the fiber 3 and one ormore sheaths is shown in FIG. 1A with regard to cross-section option D1of the probe 5.

The data collection probe 5 is an OCT probe in one embodiment. The probe5 is generalized as shown because various different exemplarycross-sections for OCT probe configurations are possible. As such, probeconfigurations having cross-sections such as the optional probecross-sections D1, D2, D3, D4, D5, D6 are provided as examples ofvarious sheath configurations and the associated variations incalibration techniques associated therewith. Additional details relatingto the various probe configurations D1, D2, D3, D4, and D5 are discussedwith regard to FIGS. 2A-2D and FIGS. 3A-3D.

In part, the invention relates to devices, probes, systems, componentsthereof and methods suitable for collecting data with respect to asample such as a blood vessel such that a suitable image can begenerated with respect to the sample. In order for a suitable image tobe generated, components of the data collection system need to beidentified and calibrated. In particular, identifying different types ofdata collection probes is of interest because as imaging systems such asOCT systems change over time and as probe designs changes, it isdesirable know if the relevant features of a given imaging system can beused as well as if certain legacy probes are compatible with a givenimaging system. Prior to discussing such features and cross-sectionalconfigurations, in FIGS. 2A-2D and FIG. 3A, it is useful to considersome additional details relating to system 1 when such a system is anOCT system.

In FIG. 1B, a generalized data collection and processing system 1 isshown. A data collection probe can be connected to the system 1 viavarious mechanisms such as optical coupler 22. As shown on the right,the data collection probe 5 can be connected in air or ex vivo state andthen inserted in a blood vessel having a lumen L. The system includes aninterferometer having a reference arm and a sample arm. Optical fiber 3is part of the sample arm of the interferometer. A reflector 25 such asa movable mirror on a track is part of the interferometer and specifiesone terminus of the reference arm. The first optical coupler 22 is inoptical communication with a second optical coupler 31 via optical path26 in one embodiment.

A light source 28, such as a swept source, produces light that passes byway of an optical path 29 into the second optical coupler 31. Lightentering the first coupler 22 is the split along optical fiber paths 35and 3. One path 35 terminates at a movable reflector 25, while samplearm portion enters probe 5 and allows light to be directed to the vesselwall VW at an angle relative to the longitudinal axis of the probe.Various types of probes 5 having different components such as backscattering doped sheaths or back scattering components can be used ascalibration features. The optical patterns that are generated in a givenimage from a given probe are also types of calibration features.

Light reflected by the movable reflector 25 passes back along opticalfiber 35 to the coupler 22. Similarly light reflected by wall VW passesback along optical fiber 3 to the coupler 22 and combines with the lightreflected by the movable reflector 25 to form an interference pattern.This combined light passes through optical path 26 to second coupler 31to optical fiber 38 and is detected by a detector 40 such as aphotodiode. The output signal from the detector 40 is processed by aprocessor or other components of an OCT system 50.

In one embodiment, the OCT system 50 is a workstation or serverconfigured to run software modules 12 and process frames or scan linesof image data corresponding to cross-sections of the blood vesselshowing features of the vessel wall such as shown in FIGS. 3B and 3C forframes F1 and F2. The probe 5 includes or images one or more calibrationfeatures 10 during a pullback through a blood vessel. In one embodimentsuch as regions of light scattering particles that can be imaged andrecognized using one or more software modules 12 and used to calibrateframes of image data.

Since OCT has difficulty resolving a blood field relative to the vesselwall VW when a probe 5 is disposed in a lumen L, a flush solution isused to clear the blood field and promote a good imaging environment.Contrast solution can flow through an annular region, a purge lumendefined by an inner layer, such as a first layer or first sheath, and anouter layer, such as a second layer or a second sheath as shown.

In contrast, as shown at the bottom right portion of FIG. 1B, at a timeT prior to insertion in a lumen, when the probe 5 is in air, this regioncan be air filled prior to use such as the ex vivo scenario shown inwhich the probe 5 is not disposed in the lumen L. The air is purged anda suitable solution such as a contrast solution or another solutionfills one or more cavities or volumes in a given probe 5. At a latertime, T+ΔT, when the probe is in the lumen, the outer sheath of thecatheter is adjacent a blood field in a blood vessel such as an arteryin contrast with the outer sheath being adjacent to air at time T. Thedifferent air and fluid interfaces can be calibration features in oneembodiment.

The presence of air and a fluid in the catheter can be used duringcalibration because of the different optical propagation and reflectionsthat occur based on which material is in the optical path during datacollection. For example, the interface between various sheaths andfluids and air changes as shown in the cross-sections of FIGS. 2A-2D and3A depending on whether the probe is calibrated in air prior toinsertion in a lumen or calibrated when in place. A purge lumen 70 isshown in the probes of FIGS. 2A-2C.

One way in which data collection probes differ relates to thecharacteristics of calibration features, such as doped layers or regionsused in a given probe, as well as how such calibration features arepositioned and which sheaths or layers are doped. The calibrationfeatures can include a scattering material arranged in a pattern such asa layer within a component of the probe. In one embodiment, thescattering material includes TiO₂. Fractional doped layers can also beselectively doped in one or more annular regions doped to form bands orregions of a sheath that scatter light.

FIGS. 2A, 2B, 2C, 2D, 3A, and 3B show various cross-sections ofexemplary intravascular imaging probes D1, D2, D3, D4, D5, and D6 thatinclude an optical fiber 3 and a sheath 7 having an outer sheath layer 7_(o) and inner sheath layer 7 _(i) and calibration features or otherproperties suitable for performing calibration. FIG. 2A depicts across-section of an intravascular imaging probe D1. Severalsubstantially concentric layers surround an optical fiber 3. Forexample, the optical fiber 3 is surrounded by a polymer layer 55 such asPET or another suitable polymer. With respect to probe D1, polymer layer55 is doped with light scattering particles. In one embodiment, thelight scattering particles in and of themselves are a calibrationfeature 10 a. This polymer layer 55 can be doped and shrunk onto thecatheter lens to induce back reflection and generate a bright ring in agiven image frame. Given the attachment to the lens, this calibrationfeature does not move across frames of image data.

In another embodiment, the light scattering particles together with thepolymer layer 55 are a calibration feature 10 a. In one embodiment, apotting layer 20 surrounds polymer layer 55 and optical fiber 3. Thepotting layer 20 can also be surrounded by another polymer layer 60. Inone embodiment, this additional polymer layer 60 can also include PET oranother suitable material. This polymer layer 60 can be doped as acalibration feature as shown in FIG. 2B. As shown, the outer sheath 7_(o), which is also typically formed from a suitable polymer, is theouter surface of the probe which typically interfaces with either air,prior to purging and insertion, or a flush solution during purging, or aflush solution such as contrast agent when disposed in a blood vessel.Purging the probe occur in the purge lumen 70. Each of the layers orstructures shown in FIGS. 2A-2D are elongate sheath or optical cores.

FIG. 2B depicts a cross-section of an intravascular imaging probe D2 inwhich polymer layer 60 is doped to form calibration feature 10 b. Otherlayers of a probe 5 such as layers 55 and sheath 7 can also be dopedsuch as between inner sheath layer 7, and outer sheath layer 7 _(o) asshown by the calibration features 10 c in probes D3 and D4. In probe D4of FIG. 2C, the optical fiber 3 is misaligned relative to centerposition C. In contrast, in FIG. 2D, optical fiber 3 is substantially inthe center of potting layer 20.

Additional details relating to exemplary cross-section of intravasculardata collection probe D5 and D6 are shown in FIGS. 3B, 3C, and 3D. Withrespect to data collection probe D5 of FIG. 3A, the probe includes acalibration feature disposed in sheath 7. Specifically, a region of thesheath is undoped UDS and has a thickness T1 and an index of refractionIR1. The sheath 7 is partially doped such that the doped portion of thesheath DS having a thickness T2 and an index of refraction IR2 isadjacent a flush zone 70 having an index of refraction IR3. The dopedregion of the sheath DS includes a concentration of scattering particlessufficient to scatter light for collection by a beam director or lens(not shown) and fiber 3.

FIGS. 3B and 3C show additional details relating to various layers of anexemplary data collection probe D6. FIG. 3D show additional detailsrelating to various layers of an exemplary data collection probe D7.FIGS. 3B and 3C show examples of an elliptical calibration feature thatincludes a second border disposed within a first border. In oneembodiment, the borders can include circles or rings in the image orborders or other calibration features.

An OCT image, such as the cross-sectional images of FIGS. 3B, 3C, and 3Dare typically acquired one scan line at a time. A sequence of samplesalong a ray originating at the catheter center to the maximum imagingdepth is referred to as a scan line in one embodiment. In one embodimentof the invention, the smallest data unit in an OCT image is called asample. A sequence of samples along a ray originating at the probecenter to the maximum imaging depth is called a scan line. An OCT imageis typically acquired one scan line at a time. A cross-sectional imagecan be formed from a set of scan lines collected as the probe rotates.Further, to image a segment of an artery or other vessel, the catheteris moved longitudinally while rotating. In this way, the probe acquiresa set of cross-sectional images in a spiral pattern. The imagesoriginate from the various scan lines associated with a slice of thevessel or artery of interest. As an example, scan lines 1, 2 and 3 areillustrated with respect to FIG. 3A. The scan lines are arranged withangles between them like spokes on a wheel.

A cross-sectional image can be formed from a set of scan lines collectedas the probe rotates. Further, to image a segment of an artery or othervessel, the catheter is moved longitudinally while rotating. In thisway, the probe acquires a set of cross-sectional images in a spiralpattern. For a given scan line, a region of scattering can be a linearsegment on the line. Various filters can be configured to be matched ona per scan line basis to identify regions of interest such as doped orbackscattering regions and undoped or substantially non-scatteringregions. In one embodiment, the software modules described herein areconfigured to operate or process a sample, a combination of samples as ascan line or a portion or a subset thereof, a combination of scan linessuch as frame or a portion or a subset thereof and combinations of theforegoing. For example, in one embodiment continuous calibration isperformed using samples or combinations of samples as scan lines.

The resultant two and three dimensional images originate from thevarious scan lines associated with a slice of the vessel or artery ofinterest. The image can be displayed as cross-sections, such as in FIGS.3A-3D. The combination of cross-sectional images allow a tomographicimage such as the three-dimensional perspective views or two-dimensionallongitudinal views to be displayed using software modules that operateson or otherwise transforms the OCT data acquired during a pullback.

FIGS. 4 and 5 illustrate a high level summary of events for varioustypes of calibration. Initially, as part of the setup process forcollecting OCT data, prior to performing a pullback, a disposable datacollection probe is connected to a patient interface unit (step 1).Connection calibration can include a search of a range of the motor usedto move the reference mirror to locate the catheter to detect scan lineinversion. The frequency aliasing that occurs and can result isperformed at the connection calibration and as part of the continuouscalibration. The auto calibration also uses a process to compensate forimage inversion or bowing as a result of frequency aliasing.

With respect to temperature related pre-pull back calibration, the sweeprange of the motor is reduced such as a sweep window of a fewmillimeters as the length of the fiber does not change after reachingequilibrium after being inserted in a blood vessel prior to pullback.

The light propagates through one or more transparent sheaths thatcomprise the catheter outer structure. Each of the interfaces can causea reflection that will be detected by OCT. Hence, it may be challengingto determine which of those reflections corresponds to the desiredoptical reference point.

As part of an OCT system, optical path lengths for a reference arm andsample arm of the interferometer used in the system need to bemaintained within certain limits for interference to occur. This can beachieved using a translatable mirror on a track or otherwise driven in alinear manner. In this way it is possible to adjust reference armposition to align the distal tip of catheter with optical path length inthe reference arm. Optical index and expansion can change optical pathlength in body. Various indexes of refraction (IR) are shown in FIG. 3Aas well as different media (blood, flush, air, etc.). The media in whichthe catheter is disposed change given the time outside a patient, theflush stage, the pullback, and again at removal. The reference mirrorcan be moved to match the path length change as part of an autocalibration process. This is performed before pullback in oneembodiment.

The calibration method is implemented as computer-based algorithm suchas various steps and loops with different phases or stages. In oneembodiment, the calibration method determines the type of datacollection probe attached to the system bases on the presence or absenceof certain features in the images generated using data collected by agiven probe. In one embodiment, the method identifies a light scatteringcalibration feature such as a calibration feature disposed in the probesuch as a doped layer.

In one embodiment, the calibration feature is disposed near the opticalfiber such as by being adjacent to the optical fiber in a materialcontacting an out surface of the optical fiber. The calibration softwaremodule is configured to change the underlying data such that it ispassed through the image data processing pipeline in a changed state.Other modules append their changes without changing the underlying dataand are passed to the next image processing module with the image dataand information and changes from a proceeding pipeline module.

At this point the connection calibration is performed to obtain dataabout the catheter from a scan of the doped sheath. The scanning forcalibration can be at first rate of rotation. In general, by using adopant which scatters light within a given data collection catheter suchas near the optical fiber or set off a distance from it in the sheath,the system can determine which version of the catheter is beingconnected to the PIU. For example, one catheter includes a doped layerthat is disposed next to the optical fiber disposed in the sheath (seeFIG. 2A). In contrast, another catheter includes a doped version of thesheath (see FIG. 2D). The sheath is separated from, but substantiallycoaxial with, the longitudinal axis of the optical fiber.

A probe, such as probe 5 in FIG. 1A, having a rotatable optical fiber 3is then inserted into the patient (step 3). Next there is a temperaturecalibration process that is performed in vivo to compensate fortemperature effects on the length of the optical fiber 3 (step 4). Thetemperature calibration can be implemented using movement of thereference mirror such as was done with regard to connection calibration(step 2). The temperature calibration typically takes a shorter periodof time relative to the connection calibration.

Next, pullback is enabled (step 5). This step can include monitoringrelating to the image data from the probe and preparing a flush. Apullback is then triggered either automatically or manually (step 6). Ablood clearing detection method can be used to trigger a pull back aftera flush sufficiently clears the lumen.

During the pullback a plurality of frames of data is collected. OCT datareceived from the catheter can be saved in various formats such as amultipage TIF file format. Each TIF file includes multiple frames ofdata. The scan lines are acquired in a polar format in one embodimentand stored in the TIF file. Each frame is a cross-section of a bloodvessel or other sample. The software-based continuous calibration methodoperates on the frames and aligns the catheter in each frame relative tothe catheter in other frames by identifying a boundary such as a ring ordoped sheath and making adjustments as to the catheter's position on aper frame basis.

One advantageous feature of the software related features describedherein relate to the imaging processing pipeline. In one embodiment,continuous calibration is one image processing module plurality of imageprocessing modules arranged in path or graph of a particular processingorder. For example, the pattern can be a sequential arrangement modulesthat is been next that is been experimentally determined to improvequality of the OCT data for particular image frame or otherwise improvethe operation downstream image processing modules.

Additionally the pattern or order of the sequence in which imageprocessing modules are arranged can also be determined based onphysiological considerations such as the interplay of a guide wire,guide wire shadows, a guide catheter, the side branches disposed in theblood vessel, stent strut detection, position of the lumen border, thedetection the lumen such as by the luminal border, plaque detection orother physiological segmentation of a blood vessel, stent malaposition,in the display of two-dimensional views of a vessel such as alongitudinal view or L mode or a cross-sectional view. Additionaldetails relating to the arrangement of image processing software modulesor possible processing pathways between such modules is provided in FIG.8.

Returning to FIG. 4, as a result of continuous calibration, frames ofdata obtained during the pullback have been processed such as byadjusting them to have their correct reference point consistent withpath length, the sample arm and the reference arm being substantiallyequal or otherwise within permitted tolerances. The calibrated pullbackimage data is then processed by subsequent image data pipeline processprocessing modules shown in FIG. 4 generally and in more detail in FIGS.5 and 8. In this way prior to performing other detection or imagetransforming stages all or a majority of the frames in the pullback arecalibrated to improve the results of subsequent processing softwaremodules by having the modules operate on calibrated image data insteadof uncalibrated image data.

Next the images/frames are modified by first establishing a thresholdfor background noise or otherwise performing a thresholding process(step 7). Under the multi-frame architecture, prior frames are deliveredto the thresholding algorithm to determine a threshold that will notresult in too much noise in the cleared lumen or too many “drop outs”(blank areas) in the lumen boundary. The thresholding process can beimplemented in one, two, three or more stages. Various thresholdingalgorithms can be used as is known in the art.

After thresholding, a continuous calibration process is started place tocontinually calibrate the diameter or position of the catheter usingframes acquired as it was pulled through the lumen (step 8). Thecalibrate frames are then used in calibrated form for the other modulesin the pipeline. Next guidewire detection is performed (step 9) and inthe future, guide catheter detection will be performed (step 10). Oncethe artifacts of the system guidewire and noise are removed, side branchdetection is performed (step 11) and stent strut detection (step 12) canbe performed.

In the multi-frame architecture, image data from the pullback is storedin memory such as in a cache. The image data is then distributed to theindividual modules for analysis or modification. Single frame detectionand processing can be performed on the image data in one embodiment on aper module basis. In addition, the data is sent to memory storage, suchas a server or hard disk, so that the individual software modules oralgorithms can request and receive previous frames of OCT image data.

Once side branch detection is accomplished, the system searches forstent struts (step 12) and then determines the lumen location (step 13).Plaque detection, stent malapposition detection, or other tissuecharacterization can then be performed (steps 14 a and 14 b step 17). 2Dor 3D display is then performed (step 15) using the processed OCT imagedata.

Continuous Calibration

Ellipse detection algorithms can be used to identify one or more sheathboundaries or interfaces between the flush solution region, blood, orone or both of the sublayers. This information can be used to align thecatheter on a per frame basis. The direction of motion of the referencemirror and its speed can be used to compensate for frequency aliaseffects.

In one embodiment, determine which catheter is being used and to performone or more calibration processes, the reference mirror is set at a homeposition. This is typically performed before a pullback as part of anautocalibrate step. Next, it is swept or scanned in the forwarddirection to a first position. A course adjustment scan can then beperformed in the backward direction beyond where it needs to be (toremove hysteresis). A fine adjustment is then made in the direction ofthe original sweep. Next using the scan lines obtained for a givenframe, the software-based system attempts to find a partial layer orfull layer of scattering particles in the sheath or catheter. Given thatan OCT probe has a rotatable fiber disposed in one or more sheaths, suchsheaths can be doped with one (see FIGS. 2A-3D and as otherwisedescribed herein) or more layers (or sublayers) (see FIG. 2B). A dopantlayer on or in the sheath can be selected to reduce unwanted reflectionswhile being detectable by software as a calibration feature.

Detection of One or More Calibration Features

Various calibration features can be used for a given intravascular datacollection probe. In one embodiment, the calibration feature can includea doped sheath that is selectively doped with scattering particles. Thesheath is a type of elongate substantially curved cover having anoptical fiber disposed therein. Such a sheath typically has anelliptical cross section which includes a circular cross-section. In oneembodiment, the software can be configured to identify a given catheterbased on its components or calibration features. In addition, thesoftware performs various filtering, detecting, and thresholding stepsto identify the sheath such as by a particular pattern or othercharacteristic on each frame. Various constraints and prior knowledge ofthe design of a given calibration element can be used to identify it. Afilter can include a stepwise function with notches sized to pick upelements along a scan line such as a thickness of doped region. A givenfilter can be represented as a matrix or other operator.

Various steps for locating a calibration feature such as a intenseregion in the image, a border or interface, an annular region, anirregular shape or other suitable features in an OCT image are describedin FIG. 6A. In one embodiment, the software and systems described hereinuse various processing steps (Steps A1-A8) and software modules toidentify a doped sheath. Various physical constraints can be tofacilitate its detection in an OCT frame. The doped sheath is typicallycircular or elliptical. The sheath can deform and twist in a vesselalthough its overall area or perimeter should not change across frames.The doped sheath is generally not disposed in the center of the bloodvessel, but rather can move around in various non-concentric positions.These geometric limitation can be used to estimate areas where thesheath appears.

Further, the thickness of the doped sheath can vary based uponmanufacturing tolerances. In addition, the dope sheath is susceptible tospeckle as shown by the dark regions in the left side of FIG. 6B incontrast with the version shown to the right in which line averaging hasbeen performed. All of these factors present challenges to tracking thedoped sheath as a calibration feature.

In one embodiment, detecting a calibration feature can be found usingthe methods and concepts described herein. Steps A1-A8 can be used on ormore times to identify a given calibration feature. Filters can be usedtogether or separately in one embodiment. The steps include averagingscan lines A1, locating an approximate region in the image in which thecatheter sheath signal is estimated to appear A4, finding candidatesheath points using one or more filters such as a 1-D filter kernel A5,measuring a thickness of the circular or elliptical signals using asecond filter such a 1-D spatial filter A6, determining circular; likelyoff-center, groupings of the candidate points A8, and selecting anellipse A8. In the case when the images are moving steps A2 and A3 canalso be performed.

In one embodiment, a first filter is used. The first filter can beconfigured to work in various possible case (in-vivo/ex-vivo and acrossthe entire doped layer thickness). Preferably, the filter is selected todeal with the scenarios that the probe and the calibration feature willbe exposed to in use. In one embodiment, one or more filters areconfigured to address the following circumstances or parameters:

-   -   Doped region/or other feature having a thickness: specifications        for the thickness of calibration feature is 0.0015″+/−0.0005″.        As a result, a minimum thickness 0.0010″ (25 um) is used.    -   Clear region: OCT resolution cell thickness of 20 uM is used in        one embodiment.    -   Mismatch region: Zero. Optical index mismatch may (ex-vivo in        air) or may not (in-vivo in contrast) be present.

For the second filter, multiple filtering operations are performed oneor more times:

-   -   Doped region/or other feature having a thickness: Varied        specifications for the thickness is (25-50 uM)    -   Clear region: Varied inversely with the doped layer thickness        (Total sheath thickness is constant)    -   Mismatch region: Zero. Optical index mismatch may (ex-vivo in        air) or may not (in-vivo in contrast) be present.

In one embodiment, if a doped sheath is not found, such as would bepresent in FIGS. 2B, 3A and 3B, the system or a calibration module triesto search for a doped sheath or ring next to the fiber 3 such as wouldbe present in FIG. 2A. The lack of a doped sheath can be an indicationthat a different type of catheter is being used, but is notdeterminative. If the system cannot find a doped layer or ring near thefiber, an error signal is generated. If this system finds and loses orcannot find a calibration feature it can mark the data as unusable orgenerate an operator alert.

Catheter Types and Features

FIG. 2A depicts one catheter type and FIGS. 2C and 2D depict showvarious features of two catheter types. The system is configured toidentify these types and others. Typically, the system looks for a dopedsheath first and absent finding that looks or a doped ring near thefiber. This is performed as part of the auto calibrate before a pullbackis performed. In this way, catheter type informs how data can beprocessed in the modular image processing pipeline.

The catheters are designed to work with a flush solution which fills theregion between the fiber and the sheath. This helps prevent bloodingress and is used to flush a lumen for OCT imaging during a pullback.The solution is configured to provide a suitable level of index matchingbetween the fiber and the sheath. When the probe is in air, the dopedsheath is easier to locate relative to when it is in blood. The dopedsheath resembles tissue to a greater degree when compared to a PET ringnear the fiber. As a result, multi-threshold sampling can be performedto identify candidates for the doped sheath. These can be scored andwhen a sufficient number of samples indicate a suitable probability thata dope sheath exists, that sheath position is used for a given frame.

Multiple Prefetch Architecture Embodiment Features

FIG. 7 depicts an image data processing architecture suitable forprocessing scan lines, samples or frames obtained using an intravascularimaging probe. Initially frames from the pullback of the probe areprovided as an input for first image data processing module, shown herein FIG. 7 as image data processing module A. In general, the steps andprocesses described herein can be configured to operate at the sample,the scan line, the frame, or the set of frames level in a givenembodiment. As a result, reference to one of the foregoing types of OCTdata can be changed to another of the types of OCT herein withoutlimitation. Thus, a reference to a frame also contemplates the relevantembodiment operating on a scan line and vice versa. In one preferredembodiment, all of the calibration, processing, and filtering stepsdescribed herein are performed with respect to scan lines.

In one embodiment, the image data processing module is configured tooperate on frames from the pullback such as Frame 1, Frame 2 and Frame 3shown. Each frame is received by the image processing module A as partof the first pass during which module operates on each frame andgenerates an output for each frame. For Frame 1 the output is output A1for Frame 1, for Frame 2 the output is output A2 for Frame 2, and forFrame 3 the output is A3 for Frame 3.

In one embodiment, each of the outputs can be a value such as a possiblevalue used to shift pixels in a frame or sample in scan line consistentwith making a sample path and reference path length substantially thesame or aligning or detecting a calibration feature in different framesor scan lines. The outputs can be operators themselves such as matricesfor application to other frames and other image processing modules. Inone embodiment module A is one of the modules shown in FIG. 8 and moduleB, is another module from FIG. 8. In one embodiment the first passperformed with respect to module A is a prefetch.

In one embodiment, image processing module A receives a frame or aplurality of scan lines from a pullback and processes the frames or scanlines generates frame or scan line outputs. The second pass can be theapplication of the output such as output A3 applied to Frame 3 shown inthe second pass, with dotted frames. Given the sequential arrangement ofmodule A proceeding module B, as shown in the top middle portion of FIG.7, Frames 1, 2 and 3 having been processed by module A resulting indotted boxes shown in Frame 1 (A1 applied), Frame 2 (A-2 applied), andFrame 3 (A3 applied).

These process frames are then provided in image data processing module Band each frame is operated upon as shown as part of a first pass suchthat outputs B1, B2, and B3 are generated. As shown, these outputs areapplied to the input frames to module B such that the resulting framesare Frame 1 with B1 applied, Frame 2 with B2 applied, and Frame 3 withB3 applied. Although the reference to A3, A2, and A1 is not maintained,the operation applied by module A carries through to the output framesby module B shown in the top right corner of FIG. 7 unless, for example,module B is configured to undo some or all of the operations of themodule A.

For example, in one embodiment module A may be configured to providecontinuous calibration on a set of frames received from a pullback. As aresult, following the application of module A, the frames would becalibrated. Further, module B would advantageously receive calibratedframes prior to the application of any additional image processing, suchas, for example, shadow removal lightening or guide wire detection.Various post pullback processing frames shown in FIG. 5 and theprocessing module shown in FIG. 8, as well as any other software modulesdescribed herein, are suitable for use with the architecture depictedand described with regard to FIG. 7 in any equivalents or extensionsthereof.

Multi-Frame Pipeline and Sequential/Order Frame Processing

In part, one embodiment of the invention relates to a multiple prefetcharchitecture. For example, in one embodiment calibration results arecomputed with regard to a first prefetch of frames of image data to bedisplayed or processed by a second prefetch of frames of image data. Inone embodiment, raw unprocessed image data can be displayed from apullback as a second stream of image data is processed according to theimage processing pipeline described herein.

As an example of the use of multi-frame data, during lumen detection,the use of two frames helps to increase the accuracy of detecting thelumen boundary. For example, a guidewire casts a shadow obscuring partof the boundary. However, a scan line can also be blocked by uncleareddebris or blood in the lumen as shown. As a result, the scan line mayimage multiple points of occlusion. However, this debris tends to besmall, and hence, by looking at previous frames, the software can beused to determine that because the wall has continuity between frames,while the debris will not, debris can be distinguished from wall.

Performing two passes on image data frames allows all of the operationsof a give module, such as module A in FIG. 7 to be performed and cached.These can be kept as an array or applied to the set of frames from thepullback. The set of modified frames or frames and such an array canthen be passed to subsequent image data processing pipeline module, suchas module B. In one embodiment, module A and module B can be any of thesoftware modules selected from image processing software pipelines shownin FIG. 8. In one embodiment, the prefetching of data for one image dataprocessing module from either a set of images obtained from an imageddata collection pullback, whether OCT, IVUS, or otherwise can be used asinputs to one or more of the processing paths of FIG. 8. In oneembodiment, one or more of the paths spanning FIG. 8 can be selectedbased on processing resources and the outputs of interest to a user.

Given that the pullback causes lumen motion, beginning the imageprocessing pipeline with continuous calibration and ending with lumendetection following a pullback is preferred. In one embodiment,continuous calibration refers to a software-based calibration by whichthe catheter or optical fiber in each frame is aligned between frames.Although, once lumen detection has been performed, one could select theprevious step to be any of those mentioned for use in a multi-framesystem.

In this way the pipeline software modules are arranged in a treestructure based on physiological and data processing constraints asshown in FIG. 8. The physiology and data input can lead to a preferredorder for modules in the pipeline. In some instances, the order improvesresults or makes certain outputs possible, such as lumen detection. Theselection of the order of swappable encapsulated software modules andthe benefits of continuous calibration lead to improved data processingresults and efficiencies.

As shown in FIG. 8, the software modules can be configured to beswappable and are configured to be encapsulated relative to each otherto reduce the likelihood of error propagation and to enable swapping ofmodules and changes to processing order for frames. Stages of the imagedata pipeline are sequenced to improve resolution and avoid errors basedon physiological constraints and a multi-stage calibration routine. Inone embodiment, the algorithm has two phases. The first phase runsduring a prefetch to collect potential guide wire regions, while, thesecond phase is executed if the pullback has multiple frames. The firstphase runs as a single frame process, which gathers information for eachframe. The second phase is executed as a multiple frame process, whichuses the information from single frame process in one embodiment.

The multi-frame system uses two or more passes to improve accuracy andreduce noise. One pass operates on and analyzes frames and generatescorrective values or other outputs based on module operating.Calibration is selected as first image data processing module. The firstpass through the calibration module identifies radial or other distancesby which the image needs to be shifted to align optical fiber receivedsignal between frames. Lumen detection is later in the pipeline becauseit is dependent on guidewire detection, side branch detection, and stentstrut detection happening before it in the pipeline, in one embodiment.

Resolving Image Features Using Low Intensity Regions and OtherStructural Features

In FIG. 9A a portion of an intravascular imaging probe is shown. Theprobe includes a beam director 180 that is adjacent to a section ofoptical fiber 190 that includes a glass section. Two fusion splicesfurther in the probe can create a low intensity region as shown by theirregular region in the lower section of FIG. 9A. Since this regioncorresponds to a section of glass, light should pass through withoutexcessive scattering.

One challenge associated with OCT and imaging probes is that rings caneasily form in an image as a result of the probe's substantiallycircular cross-section and many components. Rings of this nature, whichcan be produced by catheters, splices and other optical components of animaging system, can interfere with calibration. For example, such ringscan be locked on and erroneously processed as a calibration feature.

In one embodiment, known intensity regions such as the splice regionshown, and other regions in the image can be used to exclude certainsignals, such as rings, as candidates for a calibration feature, whensuch features are being sought after. Thus, a known low intensity regionin an image frame, based on probe components and their arrangement, canbe used to improve calibration efficiency and exclude erroneous ringsand other artifacts.

FIG. 9B shows a manufacturing problem that causes a related imagingartifact. The optical fiber 195 shown is disposed in a layer that isadhered to the fiber. This is in contrast with a calibration feature inthe imaging field with respect to which a probe can move relative to ina given embodiment. The off-center placement of the fiber can lead toadditional calibration steps. Since distance X and Y differ, whenrotating, the distances recorded as scan lines are off by an amount thatcan skew results and impact subsequent image processing. As a result,other calibrations features can be used to compensate for this result.

Continuous Calibration and Operational Triggers

In general, motor based calibration approaches do not detect deviationsin a normal operating mode of an imaging catheter. In FIG. 10A, theimaging probe is not operating properly as can be seen from theperiodically expanding pattern in the L-mode in the bottom portion ofthe figure. Similarly, the L-mode in FIG. 10B indicates that the fiberor lens is no longer relaying a signal. The continuous calibrationfeatures described herein can include a periodic tracking ofcross-sectional images. As a result, by using such cross-sectionalimages, which can include a calibration feature, a loss of lock on acalibration feature during a given calibration feature can be used tostop an imaging procedure or to otherwise alert an operator. A loss oflock or tracking with respect to a calibration feature can trigger analert or inform an operator that the pullback data cannot be used. Thethreshold can include a loss of lock over a predetermined number offrames or a predetermined time period.

Cross Frame Data Fitting, Interpolation, and Spline-Based SoftwareEmbodiments

As described herein, a set of frames of image data are generated basedupon optical signals sent and received by an optical coherencetomography data collection probe. The probe includes a probe tip whichincludes or is in optical communication with an optical fiber.

The probe is pulled back through the blood vessel as it rotates suchthat the beam of light sent to the vessel wall from the probe tip tracesa spiral as it moves along the section of the blood vessel being imaged.This section has a specified pullback distance D. A set of frames areobtained with regard to the pullback distance D.

With respect to some of the frames, errors may result that cause aparticular frame to be unusable. For example, as described herein, anellipse can be fit to a doped layer disposed relative to the sheath suchas in or within or exterior to the sheath. This doped layer is used forvarious purposes such as different calibration routines. If such anellipse fitting fails, or if the resulting ellipse fit is computederroneously relative to the location of the doped layer, the resultingfit can be considered discarded or ignored during subsequent calibrationprocessing steps.

The polymer sheath in which the probe is disposed during the pullbackgenerally has an elliptical cross-section. The optical fiber of theprobe and the sheath are visible or detectable in frames of image data.As a special case of such an ellipse, this cross-section is circular.Given the movement of the artery and the flexible nature of the sheath,the sheath can be curved or folded such that from a cross-sectionalperspective the perimeter of the sheath ranges over various regular orirregular continuous curves. Given that the sheath is a physical objectvarious parameters such as the perimeter of a given sheath should be thesame or substantially the same across frames obtained along the pullbackdistance. As a result, even if the sheath deforms from an ellipse to anirregular contour the perimeter should be constant or substantiallyconstant between frames.

In one embodiment, the perimeter is currently being estimated based onthe best fit ellipse. In another embodiments compute the perimeterdirectly from the computed offsets and this might be more accurate,although it might be more prone to noise in certain circumstances. Inone embodiment, the mean diameter of the sheath can be used as anothermetric which should generally remain constant between frames. Theposition of the optical fiber can also be tracked across frames. In oneembodiment, one or more calibration software modules are used to performthe spline-based or elliptical fitting described herein. The softwaremodules can be configured to include constraints to preventdiscontinuities and jumps between frames.

Various other parameters can be tracked including without limitation:eccentricity of ellipse, center position of ellipse, perimeter ofellipse, and perimeter of offsets. Eccentricity of ellipse—ifeccentricity varies wildly from one frame to a next, that could indicatean error in ellipse fit and thus be an outlier. In one embodiment,perimeter of offsets is potentially more accurate as a calibrationmetric than perimeter of ellipse, but this could also be subject toerrors based on false offset detections that are essentially ignored byellipse fit.

In general, if an ellipse can be fit to the sheath or scatteringparticles disposed therein for a given frame, the frame is likely to beuseful for calibration and imaging. This elliptical fitting is used aspart of one or more calibration routines. In one embodiment, suchelliptical fitting on spline-based fitting is performed using one ormore steps as outlined in FIG. 11.

Offsets are computed for each line within a frame, the ellipse is fit tothe offsets. For each frame, a size value for the ellipse such as a meandiameter or mean radius of the ellipse is saved as an offset value for agiven frame. All frames in the pullback are partitioned into 1 mmdiscrete windows. The median offset within each window, based on the perframe offset values, is used as the value for fitting the spline.

The spline effectively models the offset for all frames, and due to themedian being used on each window, outlier offsets are effectivelyignored. Because the spline fit will be smooth, it is a suitable valueto use for calibration. The spline does not select frames to bedisplayed. The spline does effectively interpolate offset values forframes on which the offset detection failed or for which the detectedoffset was computed erroneously (an outlier).

In general, features which can be tracked for consistency across framessuch as a locus for possible fiber core positions, sheath diameter,sheath perimeter, and other factors outlined herein can be used togenerate a relationship for interpolating across frames. This is usefulin cases where the sheath detection or elliptical fit fail. When such anerror occurs, a polynomial spline or other interpolation method can beused to obtain calibration correction values for the frames that had theerror condition. Specifically, interpolation refers to the process ofextracting suitable calibration correction values for frames on whichoffsets could not be computed by using the valid offsets fromsurrounding frames in which the offsets are computed correctly.

There are several error conditions that would render the spline fitunusable. In one embodiment, processing of frames using a polynomial fitor spline fit based method terminates or is otherwise is aborted if oneor more of the following conditions apply:

-   -   The computed difference between median offset from one window to        the next exceeds a threshold (about 20 microns)    -   A median value for any of the windows cannot be found. This        occurs if no frame within the window has a valid offset        measurement.    -   Over ½ of all frames have no valid computed mean diameter        (offset).

In one embodiment, the data fitting of frame of image data is performedusing a spline or spline fitting based method. In one embodiment, theinputs of the data fitting algorithm for continuous calibration areinputs are the median offset values computed on each 1 mm window in thepullback. The parameters are the median offset values computed in eachwindow of size 1 mm along the pullback. Performing a polynomial fitrelative to a set of values obtained for the different windows that isrepresentative of the ellipse such as its size or position is used totest the likelihood that the ellipse has been found. If the fit of theellipse parameter is consistent over the windows, this supports theposition that the correct feature has been identified in each imageframe.

The fitting process performs a fit with regard to the offset values suchas an ellipse size value or parameter that are computed for each frame.If spline algorithm or continuous calibration otherwise does not workfor a particular reason, the software is configured to direct the userto the manual verification/adjustment screen. The probe image isprovided to the user for manual selection or to provide a set ofcandidates for the user to evaluate or request more information from theuser.

Data Collection Probe Embodiments and Parameters

In one embodiment, an inner layer, a middle layer, or an outer layer ofthe probe can be doped. In one embodiment, two closely-spaced layers areused to provide a double-line reflection. These double layers can bedisposed in the sheath or outer layer of the probe in one embodiment.The double-line reflection configuration can be used to mitigatespurious reflections.

In one embodiment, a data collection probe can include two layers havinga space in between the doped material in separate components, ratherthan two layers within the same component. For example, a combination ofcomponents with either full-wall thickness of doped material (such as aPET layer around near the optical fiber) or doped layer(s) (such as thewindow tubing with doped inner-layer). A combination of doped rings canbe used in such a manner, for example: doped lens PET and doped windowtubing—each with doped full-wall (not layered), or one or both with adoped layer(s) can be used for some data collection probe embodiments.

In one embodiment, the flexible sheath through which light passes to andfrom the probe tip is made from a thermoplastic material. An example ofsuch a material is a polyether-polyamide block co-polymer. A partiallydoped sheath can be achieved using various plastic materials that can beformed or molded into a tube or other shape.

In one embodiment, the doped layer is disposed within the sheath and hasa thickness that ranges from about 0.001 inches to about 0.004 inches.In one embodiment, a substantially scattering particle free layer isdisposed within the sheath and has a thickness that ranges from 0 toabout 0.004 inches.

In one embodiment, the invention relates to an optical coherencetomography probe. The probe includes a substantially transparent curvedcover defining a first bore and comprising a polymer, the substantiallytransparent curved cover comprising a substantially elliptical crosssection comprising a first annular region having a first annularthickness T1 and a second annular region, the second annular regiondoped with a light scattering material and having a second annularthickness T2, the first annular region substantially free of the lightscattering material; a beam director; a torque wire defining a secondbore; a rotatable optical fiber in optical communication with the beamdirector, the rotatable optical fiber disposed in the second bore, thetorque wire slidably disposed within the first bore.

Pixel and Clear Layer Parameters for Sheath for Intravascular Probe

As shown in FIG. 12, an exemplary sheath 200 is illustrates a magnifiedview 210 of various interface layers for the sheath 200. The interfacelayers include the outer layer or outer diameter of the sheathidentified as OD. One layer 215 of sheath 200 is substantially free oflight scattering particles as a dopant and has a thickness T1. One layer220 of sheath 200 includes light scattering particles as a dopant andhas a thickness T2.

In one embodiment, the doped sheath used for a particular calibrationfeature is adjusted to account for OCT resolution. The OCT resolutioncell in the sheath 200 is smaller (better) than the resolution in air byl/n-material, where n-material is the index of refraction of thematerial. In one embodiment, the sheath 200 is a polymer, and mostpolymers have an index of ˜1.5. As a result, 8-20 um resolution in airis a ˜12.5 um resolution cell in the polymer of the sheath 200.

In one embodiment, the clear layer, layer 215, appears thinner by oneresolution cell than actual while the doped layer 210 appears thicker byone resolution cell than actual under OCT. The resolution issuesresulting from the use of OCT can be evaluating using two equations asfollows:

DLT+1*RCm=CLT−1*RCm (desired condition of equal apparent thickness)  (1)

Where CLT=clear layer thickness, DLT=doped layer thickness,RCm=Resolution Cell, material and

DLT+CLT=TT, TT=total sheath wall thickness  (2)

As an example, for a 100 um window thickness (actual), the doped layeris 37.5 um and clear layer is 62.5 um (actual), RCm=˜12.5 um. Thisyields the desired ratio of 1:1, apparent layer thicknesses.(37.5+12.5=62.5−12.5). The build ratio for the two layers of the sheathis then 3:5 for this TT and RCm. [37.5:62.5=3:5, where 3:5 is expressedin units of RCm—the minimum quanta for detection.

As a result, the minimum sheath wall is when CLT—1*RCm=1RCm, soCLT=2*RCm, or 25 um. Then the minimum sheath wall thickness is 37.5 umand the DLT is 12.5 um. In this case the build ratio is 1:2. Thisassumes the minimum detectable thickness is just 1 RCm.

Speckle reduction can reduce the uncertainly on the apparent wallthickness by 1/sqrt(n), where n is the number of sampled lines. So RCmcan go down by 1/sqrt(n). In our case, we can average 8 lines [(spotsize*number of lines per cross section)/circumference=8], so RCm, avgbecomes 4.4 um.

In one embodiment, the ratio of T1 and T2 ranges from greater than aboutzero to 1. In one embodiment, the boundary between the DS and UDSregions is a calibration feature. In one embodiment, the ratio of T2 toT1 is about 1:5. In one embodiment, the ratio of T2 to T1 is about 3:5.In one embodiment, the ratio of T2 to T1 is about 4:6.

In one embodiment, the thickness of the sheath 200 is T1+T2. In oneembodiment, T1+T2 is about 60 μm. In one embodiment, T1+T2 is about 100μm. In one embodiment, T1+T2 is about 120 μm. In one embodiment, T1+T2is about 140 μm. In one embodiment, T1+T2 is about 160 μm. In oneembodiment, T1+T2 is about 180 μm. In one embodiment, T1+T2 is about 200μm. In one embodiment, the light scattering material comprises titaniumdioxide.

In one embodiment, the calibration feature includes an arrangement oflight scattering particles that are sized and positioned such thatsingle scattering is maintained with respect to incident light. Thus, inone embodiment a multiple scattering threshold is set as constraint whendisposing scattering particles in a given elongate layer or film of adata collection probe. This follows because attenuation will increaserapidly while return signal (doped layer brightness) will not increaseas much.

In the description, the invention is discussed in the context of opticalcoherence tomography; however, these embodiments are not intended to belimiting and those skilled in the art will appreciate that the inventioncan also be used for other imaging and diagnostic modalities or opticalsystems in general.

The terms light and electromagnetic radiation are used interchangeablyherein such that each term includes all wavelength (and frequency)ranges and individual wavelengths (and frequencies) in theelectromagnetic spectrum. Similarly, the terms device and apparatus arealso used interchangeably. In part, embodiments of the invention relateto or include, without limitation: sources of electromagnetic radiationand components thereof; systems, subsystems, and apparatuses thatinclude such sources; mechanical, optical, electrical and other suitabledevices that can be used as part of or in communication with theforegoing; and methods relating to each of the forgoing. Accordingly, asource of electromagnetic radiation can include any apparatus, matter,system, or combination of devices that emits, re-emits, transmits,radiates or otherwise generates light of one or more wavelengths orfrequencies.

One example of a source of electromagnetic radiation is a laser. A laseris a device or system that produces or amplifies light by the process ofstimulated emission of radiation. Although the types and variations inlaser design are too extensive to recite and continue to evolve, somenon-limiting examples of lasers suitable for use in embodiments of theinvention can include tunable lasers (sometimes referred to as sweptsource lasers), superluminescent diodes, laser diodes, semiconductorlasers, mode-locked lasers, gas lasers, fiber lasers, solid-statelasers, waveguide lasers, laser amplifiers (sometimes referred to asoptical amplifiers), laser oscillators, and amplified spontaneousemission lasers (sometimes referred to as mirrorless lasers orsuperradiant lasers).

Non-Limiting Software Features and Embodiments

The following description is intended to provide an overview of devicehardware and other operating components suitable for performing themethods of the invention described herein. This description is notintended to limit the applicable environments or the scope of theinvention. Similarly, the hardware and other operating components may besuitable as part of the apparatuses described above. The invention canbe practiced with other system configurations, including personalcomputers, multiprocessor systems, microprocessor-based or programmableelectronic device, network PCs, minicomputers, mainframe computers, andthe like. The invention can also be practiced in distributed computingenvironments where tasks are performed by remote processing devices thatare linked through a communications network such as in different roomsof a catheter or cath lab.

Some portions of the detailed description are presented in terms ofalgorithms and symbolic representations of operations on data bitswithin a computer memory. These algorithmic descriptions andrepresentations can be used by those skilled in the computer andsoftware related fields. In one embodiment, an algorithm is here, andgenerally, conceived to be a self-consistent sequence of operationsleading to a desired result. The operations performed as methods stopsor otherwise described herein are those requiring physical manipulationsof physical quantities. Usually, though not necessarily, thesequantities take the form of electrical or magnetic signals capable ofbeing stored, transferred, combined, transformed, compared, andotherwise manipulated.

Unless specifically stated otherwise as apparent from the followingdiscussion, it is appreciated that throughout the description,discussions utilizing terms such as “processing” or “computing” or“searching” or “detecting” or “measuring” or “calculating” or“comparing” “fitting” or “interpolating” or “applying” or “thresholding”or “filtering” or “calibrating” or “generating” or “determining” or“displaying,” or Boolean logic or other set related operations or thelike, refer to the action and processes of a computing device, orelectronic device, that manipulates and transforms data represented asphysical (electronic) quantities within the computer system's orelectronic devices' registers and memories into other data similarlyrepresented as physical quantities within electronic memories orregisters or other such information storage, transmission or displaydevices.

The present invention, in some embodiments, also relates to apparatusfor performing the operations herein. This apparatus may be speciallyconstructed for the required purposes, or it may comprise a generalpurpose computer selectively activated or reconfigured by a computerprogram stored in the computer.

The algorithms and displays presented herein are not inherently relatedto any particular computer or other apparatus. Various general purposesystems may be used with programs in accordance with the teachingsherein, or it may prove convenient to construct more specializedapparatus to perform the required method steps. The required structurefor a variety of these systems will appear from the description below.In addition, the present invention is not described with reference toany particular programming language, and various embodiments may thus beimplemented using a variety of programming languages.

Embodiments of the invention may be embodied in many different forms,including, but in no way limited to, computer program logic for use witha processor (e.g., a microprocessor, microcontroller, digital signalprocessor, or general purpose computer), programmable logic for use witha programmable logic device, (e.g., a Field Programmable Gate Array(FPGA) or other programmable logic device), discrete components,integrated circuitry (e.g., an Application Specific Integrated Circuit(ASIC)), or any other means including any combination thereof. In atypical embodiment of the present invention, some or all of theprocessing of the data collected using an OCT probe and theprocessor-based system is implemented as a set of computer programinstructions that is converted into a computer executable form, storedas such in a computer readable medium, and executed by a microprocessorunder the control of an operating system. Thus, query response and inputdata are transformed into processor understandable instructions suitablefor generating one or more or prefetches, calibration corrections,offsets, detecting lumen borders, comparing measured perpendiculardistances relative to set thresholds, and otherwise performing imagecomparison, thresholding, signal processing, pattern matching, artifactremoval, continuous calibration, and other features and embodimentsdescribed above.

Computer program logic implementing all or part of the functionalitypreviously described herein may be embodied in various forms, including,but in no way limited to, a source code form, a computer executableform, and various intermediate forms (e.g., forms generated by anassembler, compiler, linker, or locator). Source code may include aseries of computer program instructions implemented in any of variousprogramming languages (e.g., an object code, an assembly language, or ahigh-level language such as Fortran, C, C++, JAVA, or HTML) for use withvarious operating systems or operating environments. The source code maydefine and use various data structures and communication messages. Thesource code may be in a computer executable form (e.g., via aninterpreter), or the source code may be converted (e.g., via atranslator, assembler, or compiler) into a computer executable form.

The computer program may be fixed in any form (e.g., source code form,computer executable form, or an intermediate form) either permanently ortransitorily in a tangible storage medium, such as a semiconductormemory device (e.g., a RAM, ROM, PROM, EEPROM, or Flash-ProgrammableRAM), a magnetic memory device (e.g., a diskette or fixed disk), anoptical memory device (e.g., a CD-ROM), a PC card (e.g., PCMCIA card),or other memory device. The computer program may be fixed in any form ina signal that is transmittable to a computer using any of variouscommunication technologies, including, but in no way limited to, analogtechnologies, digital technologies, optical technologies, wirelesstechnologies (e.g., Bluetooth), networking technologies, andinternetworking technologies. The computer program may be distributed inany form as a removable storage medium with accompanying printed orelectronic documentation (e.g., shrink-wrapped software), preloaded witha computer system (e.g., on system ROM or fixed disk), or distributedfrom a server or electronic bulletin board over the communication system(e.g., the Internet or World Wide Web).

Hardware logic (including programmable logic for use with a programmablelogic device) implementing all or part of the functionality previouslydescribed herein may be designed using traditional manual methods, ormay be designed, captured, simulated, or documented electronically usingvarious tools, such as Computer Aided Design (CAD), a hardwaredescription language (e.g., VHDL or AHDL), or a PLD programming language(e.g., PALASM, ABEL, or CUPL).

Programmable logic may be fixed either permanently or transitorily in atangible storage medium, such as a semiconductor memory device (e.g., aRAM, ROM, PROM, EEPROM, or Flash-Programmable RAM), a magnetic memorydevice (e.g., a diskette or fixed disk), an optical memory device (e.g.,a CD-ROM), or other memory device. The programmable logic may be fixedin a signal that is transmittable to a computer using any of variouscommunication technologies, including, but in no way limited to, analogtechnologies, digital technologies, optical technologies, wirelesstechnologies (e.g., Bluetooth), networking technologies, andinternetworking technologies. The programmable logic may be distributedas a removable storage medium with accompanying printed or electronicdocumentation (e.g., shrink-wrapped software), preloaded with a computersystem (e.g., on system ROM or fixed disk), or distributed from a serveror electronic bulletin board over the communication system (e.g., theInternet or World Wide Web).

Various examples of suitable processing modules are discussed below inmore detail. As used herein a module refers to software, hardware, orfirmware suitable for performing a specific data processing or datatransmission task. Typically, in a preferred embodiment a module refersto a software routine, program, or other memory resident applicationsuitable for receiving, transforming, routing and processinginstructions, or various types of data such as OCT scan data, kernelfilters, filters, thresholding, pattern matching, interferometer signaldata, guide wire locations, shadow region locations, side branchlocations, side branch diameters, intensity profiles, and otherinformation of interest.

Computers and computer systems described herein may include operativelyassociated computer-readable media such as memory for storing softwareapplications used in obtaining, processing, storing and/or communicatingdata. It can be appreciated that such memory can be internal, external,remote or local with respect to its operatively associated computer orcomputer system.

Memory may also include any means for storing software or otherinstructions including, for example and without limitation, a hard disk,an optical disk, floppy disk, DVD (digital versatile disc), CD (compactdisc), memory stick, flash memory, ROM (read only memory), RAM (randomaccess memory), DRAM (dynamic random access memory), PROM (programmableROM), EEPROM (extended erasable PROM), and/or other likecomputer-readable media.

In general, computer-readable memory media applied in association withembodiments of the invention described herein may include any memorymedium capable of storing instructions executed by a programmableapparatus. Where applicable, method steps described herein may beembodied or executed as instructions stored on a computer-readablememory medium or memory media. These instructions may be softwareembodied in various programming languages such as C++, C, Java, and/or avariety of other kinds of software programming languages that may beapplied to create instructions in accordance with embodiments of theinvention.

A storage medium may be non-transitory or include a non-transitorydevice. Accordingly, a non-transitory storage medium or non-transitorydevice may include a device that is tangible, meaning that the devicehas a concrete physical form, although the device may change itsphysical state. Thus, for example, non-transitory refers to a deviceremaining tangible despite this change in state.

The aspects, embodiments, features, and examples of the invention are tobe considered illustrative in all respects and are not intended to limitthe invention, the scope of which is defined only by the claims. Otherembodiments, modifications, and usages will be apparent to those skilledin the art without departing from the spirit and scope of the claimedinvention.

The use of headings and sections in the application is not meant tolimit the invention; each section can apply to any aspect, embodiment,or feature of the invention.

Throughout the application, where compositions are described as having,including, or comprising specific components, or where processes aredescribed as having, including or comprising specific process steps, itis contemplated that compositions of the present teachings also consistessentially of, or consist of, the recited components, and that theprocesses of the present teachings also consist essentially of, orconsist of, the recited process steps.

In the application, where an element or component is said to be includedin and/or selected from a list of recited elements or components, itshould be understood that the element or component can be any one of therecited elements or components and can be selected from a groupconsisting of two or more of the recited elements or components.Further, it should be understood that elements and/or features of acomposition, an apparatus, or a method described herein can be combinedin a variety of ways without departing from the spirit and scope of thepresent teachings, whether explicit or implicit herein.

The use of the terms “include,” “includes,” “including,” “have,” “has,”or “having” should be generally understood as open-ended andnon-limiting unless specifically stated otherwise.

The use of the singular herein includes the plural (and vice versa)unless specifically stated otherwise. Moreover, the singular forms “a,”“an,” and “the” include plural forms unless the context clearly dictatesotherwise. In addition, where the use of the term “about” is before aquantitative value, the present teachings also include the specificquantitative value itself, unless specifically stated otherwise.

It should be understood that the order of steps or order for performingcertain actions is immaterial so long as the present teachings remainoperable. Moreover, two or more steps or actions may be conductedsimultaneously.

Where a range or list of values is provided, each intervening valuebetween the upper and lower limits of that range or list of values isindividually contemplated and is encompassed within the invention as ifeach value were specifically enumerated herein. In addition, smallerranges between and including the upper and lower limits of a given rangeare contemplated and encompassed within the invention. The listing ofexemplary values or ranges is not a disclaimer of other values or rangesbetween and including the upper and lower limits of a given range.

It is to be understood that the figures and descriptions of theinvention have been simplified to illustrate elements that are relevantfor a clear understanding of the invention, while eliminating, forpurposes of clarity, other elements. Those of ordinary skill in the artwill recognize, however, that these and other elements may be desirable.However, because such elements are well known in the art, and becausethey do not facilitate a better understanding of the invention, adiscussion of such elements is not provided herein. It should beappreciated that the figures are presented for illustrative purposes andnot as construction drawings. Omitted details and modifications oralternative embodiments are within the purview of persons of ordinaryskill in the art.

It can be appreciated that, in certain aspects of the invention, asingle component may be replaced by multiple components, and multiplecomponents may be replaced by a single component, to provide an elementor structure or to perform a given function or functions. Except wheresuch substitution would not be operative to practice certain embodimentsof the invention, such substitution is considered within the scope ofthe invention.

The examples presented herein are intended to illustrate potential andspecific implementations of the invention. It can be appreciated thatthe examples are intended primarily for purposes of illustration of theinvention for those skilled in the art. There may be variations to thesediagrams or the operations described herein without departing from thespirit of the invention. For instance, in certain cases, method steps oroperations may be performed or executed in differing order, oroperations may be added, deleted or modified.

What is claimed is:
 1. A method of detecting a calibration featuredisposed in a vessel having a vessel wall, the vessel scanned using anintravascular imaging probe, the method comprising: storing image dataobtained during a pullback through the vessel in a memory device, theimage data comprising a plurality of frames, each frame comprising scanlines; averaging scan lines for a first frame of the plurality of framesto obtain a speckle reduced first frame; identifying a region in thespeckle reduced first frame in which the calibration feature isestimated to appear; identifying candidate samples of the calibrationfeature; identifying a region defined by the candidate samples using athickness of at least a portion of the calibration feature; and fittinga curve to the candidate samples to define a boundary of the calibrationfeature in the speckle reduced first frame.
 2. The method of claim 1wherein the intravascular imaging probe comprises an optical fiber and abeam director in optical communication with the optical fiber.
 3. Themethod of claim 2 wherein the calibration feature is a substantiallyelliptical cross-section of substantially transparent curved covercomprising a polymer, wherein the elliptical cross section comprises afirst annular region and a second annular region, the second annularregion doped with a light scattering material.
 4. The method of claim 3wherein the thickness is an annular thickness of the second annularregion and wherein the second annular region is disposed concentricallywithin the first annular region.
 5. The method of claim 4 furthercomprising receiving the thickness from a device attached to theintravascular imaging probe.
 6. The method of claim 5 further comprisingsearching for the second annular region using the thickness.
 7. Themethod of claim 2 further comprising rotating the optical fiber and thebeam director within the calibration feature and generating an image ofa cross-section of the blood vessel, the image comprising a firstannular region having a first optical intensity and a second annularregion having a second optical intensity, the second optical intensitybrighter than the first optical intensity.
 8. The method of claim 3further comprising averaging scan lines for a second frame of theplurality of frames to obtain a speckle reduced second frame;identifying a region in the speckle reduced second frame in which thecalibration feature is estimated to appear; identifying candidatesamples of the calibration feature using a first spatial filter;identifying a region defined by the candidate samples using a secondspatial filter having a thickness of at least a portion of thecalibration feature; and fitting a curve to the candidate samples todefine a boundary of the calibration feature in the speckle reducedsecond frame.
 9. The method of claim 1 further comprising identifying adark region having a first intensity in one or more of the scan lines ofa frame; and excluding optical signals having a second intensityappearing in the dark region if the second intensity is greater than thefirst intensity.
 10. The method of claim 1 further comprising whereinone or more of the identifying steps are performed using one or morefilters.
 11. The method of claim 1 further comprising rejecting imagedata associated with the boundary of the calibration feature, when ashape of the boundary is irregular or exceeds a shape threshold.
 12. Anintravascular image data processing system comprising: a memory; and aprocessor in communication with the memory, wherein the memory comprisesinstructions executable by the processor to cause the processor to:continuously calibrate a plurality of frames comprising cross-sectionalimages using an elliptical calibration feature that changes between twoor more frames of the plurality of frames, the plurality of framescomprising data collected during a pullback of a probe through a bloodvessel; detect a guidewire in the plurality of frames; and display aplurality of continuously calibrated frames.
 13. The system of claim 12wherein continuously calibrate comprises identifying the ellipticalcalibration feature in at least a majority of the plurality of theframes.
 14. The system of claim 13 wherein identifying the ellipticalcalibration feature is performed using one or more constraints selectedfrom the group consisting of non-concentric positioning of calibrationfeature, a circular profile of calibration feature, a perimeter measureof calibration feature, an area measure of calibration feature, athickness of a brighter annular subset of the calibration feature, athickness of a brighter annular subset of the calibration feature andthickness of a doped region of the calibration feature.
 15. The systemof claim 13 further comprising instructions executable by the processorto cause the processor to: divide the plurality of frames into aplurality of windows and fit a curve relative to a measurement of theelliptical calibration feature across the plurality of windows.
 16. Thesystem of claim 13 further comprising instructions executable by theprocessor to cause the processor to: detect one or more side branches inthe continuously calibrated frames and display a side branch on one ormore of the continuously calibrated frames.
 17. The system of claim 16further comprising instructions executable by the processor to cause theprocessor to: detect a lumen of a blood vessel on a per frame basis forthe continuously calibrated frames and display the lumen of the bloodvessel in the continuously calibrated frames.
 18. The system of claim 17further comprising instructions executable by the processor to cause theprocessor to: detect a guide catheter on a per frame basis for thecontinuously calibrated frames.
 19. The system of claim 16 furthercomprising instructions executable by the processor to cause theprocessor to: detect a stent strut; and display a stent strut on one ormore of the continuously calibrated frames.
 20. The system of claim 16further comprising instructions executable by the processor to cause theprocessor to: detect one or more side branches on a per frame basis inthe continuously calibrated frames; detect one or more stent struts inthe continuously calibrated frames on a per frame basis; detect a lumenof a blood vessel on a per frame basis for the continuously calibrated;and display a side branch, one or more stents struts, and the lumen onone or more of the continuously calibrated frames.
 21. The system ofclaim 13 wherein the elliptical calibration feature comprises a firstborder, wherein the border changes between the two or more frames. 22.The system of claim 21 wherein the elliptical calibration featurecomprises a second border disposed within the first border, wherein thesecond border changes between the two or more frames.
 23. The system ofclaim 21 wherein continuously calibrate a plurality of frames comprisescalibrating each scan line prior to generating a frame of calibratedscan lines.
 24. The system of claim 21 further comprising instructionsexecutable by the processor to cause the processor to: generate an alertin response to a shape of the first border or a loss of calibrationfeature tracking.